Healing ALS Registry Observational Study (HAROS)

NCT07233148 | Recruiting

• 1 other identifier: 25-12-299-2201
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational, online study of people diagnosed with ALS, MND or PLS referred to as HAROS (Healing ALS Registry Observational Study). Participants will enter information into an online ALS registry once per month, including their ALSFRS-R data, certain other symptoms, dietary intake, supplements, medications and other therapies, both conventional and integrative. Participants will also enter the hours spent on optional self-study and free online education. The investigators will assess the effectiveness of various therapies and education by measuring physical outcomes.

Conditions

Motor Neuron Disease (MND); Primary Lateral Sclerosis (PLS); Amyotrophic Lateral Sclerosis (ALS)

Keywords

ALS; PLS; MND; Amyotrophic Lateral Sclerosis; Primary Lateral Sclerosis; Motor Neuron Disease; Motor Neurone Disease

Outcome Measures

Primary Outcomes (3)

• ALSFRS-R ALS Functional Rating Scale - Revised

  ALS Functional Ratings Scale is a set of 12 questions, with a maximum of 4 points per question and measures physical functionality. Outcomes are measured at a point in time and range from 0 for no functionality to 48 for full functionality in all areas measured. The higher the score the better the outcome.

  Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.

• ALSSQ ALS Supplementary Questionnaire

  ALS Supplementary Questionnaire (ALSSQ) is a measure of physical functionality and symptoms that are not measured in the ALSFRS-R scale. Items measured in the ALSSQ are energy level, sleep quality and quantity, pain, fasciculations, muscle cramps, mucous, mental clarity, head drop and showing emotions inappropriately. There are 18 questions, 4 points each, for a maximum of 72 points. The higher this score, the better the outcome.

  Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.

• Mindset Score

  Mindset is measured by questions about A) positivity, maximum 400 points, B) belief in ability to get well and mental blocks to healing, maximum 18 points, and C) a Modified PANAS (Positive and Negative Affect Schedule), maximum of 50 positive points and 50 negative points. The investigators will analyze how these measures of mindset correlate with ALS/MND/PLS outcomes.

  Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.

Secondary Outcomes (22)

• Weight

  Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.

• Change in blood inflammation markers Set 1

  Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.

• Change in blood inflammation markers Set 2

  Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.

• Change in blood oxidative stress markers Set 1

  Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.

• Change in blood oxidative stress markers Set 2

  Participants will be assessed at baseline and each 1 year anniversary from the baseline until participant withdraws from the study for any reason, including death from any cause, up to a maximum of 10 years from baseline.

Study Arms (4)

ALS/MND less than 3 years since diagnosis

Those diagnosed with ALS, Amyotrophic Lateral Sclerosis or MND, Motor Neuron Disease (other countries) and time since diagnosis is less 3 years, or 36 months, as of the date they join the study.

Other: Education about treatment options; Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.; Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.; Other: Diet, various diets will be observed; Other: Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies; Drug: ALS medications and other medications; Other: Physical and emotional support

PLS less than 3 years since diagnosis

Those diagnosed with PLS, Primary Lateral Sclerosis, and time since diagnosis is less 3 years, or 36 months, as of the date they join the study.

Other: Education about treatment options; Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.; Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.; Other: Diet, various diets will be observed; Other: Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies; Drug: ALS medications and other medications; Other: Physical and emotional support

ALS/MND 3 years or greater since diagnosis

Those diagnosed with ALS, Amyotrophic Lateral Sclerosis or MND, Motor Neuron Disease (other countries) and time since diagnosis is 3 years or greater as of the date they join the study.

Other: Education about treatment options; Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.; Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.

PLS 3 years or greater since diagnosis.

Those diagnosed with PLS, Primary Lateral Sclerosis and time since diagnosis is 3 years or greater as of the date they join the study.

Other: Education about treatment options; Dietary Supplement: Dietary Supplements: Vitamins, Minerals, Herbs, etc.; Behavioral: Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc.

Interventions

Dietary Supplements: Vitamins, Minerals, Herbs, etc. DIETARY_SUPPLEMENT

The investigators are observing type and quantity of dietary supplements, vitamins, minerals and herbs that ALS/MND/PLS patients take regularly.

ALS/MND 3 years or greater since diagnosis; ALS/MND less than 3 years since diagnosis; PLS 3 years or greater since diagnosis.; PLS less than 3 years since diagnosis

ALS medications and other medications DRUG

Many ALS/MND/PLS patients find benefit from prescription and other drugs. These will be observed and analyzed for effect on quality of life and outcomes.

ALS/MND less than 3 years since diagnosis; PLS less than 3 years since diagnosis

Physical and emotional support OTHER

Study participants are asked to record the level of emotional and physical support they get from family members, caregivers, friends, medical professionals and members of their community. The investigators will analyze how the perceived level of emotional and physical support affect outcomes.

ALS/MND less than 3 years since diagnosis; PLS less than 3 years since diagnosis

Diet, various diets will be observed OTHER

May ALS/MND/PLS patients follow a specific diet such as ketogenic, vegetarian, gluten-free, dairy-free, and/or sugar-free. The investigators will analyze which diets are most efficacious.

ALS/MND less than 3 years since diagnosis; PLS less than 3 years since diagnosis

Education about treatment options OTHER

Education about treatment options and integrative therapies is optional. It is available online and is free for all study participants.

ALS/MND 3 years or greater since diagnosis; ALS/MND less than 3 years since diagnosis; PLS 3 years or greater since diagnosis.; PLS less than 3 years since diagnosis

Meditation, Prayer, Talk Therapy, Affirmations, Journaling, etc. BEHAVIORAL

Many of those diagnosed with ALS/MND/PLS regularly engage in meditation, prayer and other behavioral protocols. These will be observed and analyzed to see if, and to what degree they affect outcomes.

ALS/MND 3 years or greater since diagnosis; ALS/MND less than 3 years since diagnosis; PLS 3 years or greater since diagnosis.; PLS less than 3 years since diagnosis

Exercise, physical therapy, occupational therapy, speech therapy, sauna, EMS, massage and other therapies OTHER

Exercise, physical therapy, occupational therapy, speech therapy, sauna, massage, EMS (electro-muscular stimulation), red light therapy and other physical modalities will be observed and analyzed for effect on outcomes.

ALS/MND less than 3 years since diagnosis; PLS less than 3 years since diagnosis

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators are studying adult non-smokers who have a diagnosis of ALS, MND or PLS, irrespective of time since diagnosis.

You may qualify if:

• Diagnosed with ALS, MND or PLS

You may not qualify if:

• Smokers

Sponsors & Collaborators

• Healing Advocates Registry and Ministry: lead

Study Sites (1)

Virtual

Park City, Utah, 84098, United States

RECRUITING

Related Publications (12)

• Boddy SL, Giovannelli I, Sassani M, Cooper-Knock J, Snyder MP, Segal E, Elinav E, Barker LA, Shaw PJ, McDermott CJ. The gut microbiome: a key player in the complexity of amyotrophic lateral sclerosis (ALS). BMC Med. 2021 Jan 20;19(1):13. doi: 10.1186/s12916-020-01885-3.

  PMID: 33468103 BACKGROUND

• Peters S, Broberg K, Gallo V, Levi M, Kippler M, Vineis P, Veldink J, van den Berg L, Middleton L, Travis RC, Bergmann MM, Palli D, Grioni S, Tumino R, Elbaz A, Vlaar T, Mancini F, Kuhn T, Katzke V, Agudo A, Goni F, Gomez JH, Rodriguez-Barranco M, Merino S, Barricarte A, Trichopoulou A, Jenab M, Weiderpass E, Vermeulen R. Blood Metal Levels and Amyotrophic Lateral Sclerosis Risk: A Prospective Cohort. Ann Neurol. 2021 Jan;89(1):125-133. doi: 10.1002/ana.25932. Epub 2020 Nov 6.

  PMID: 33068316 BACKGROUND

• Filippini T, Tesauro M, Fiore M, Malagoli C, Consonni M, Violi F, Iacuzio L, Arcolin E, Oliveri Conti G, Cristaldi A, Zuccarello P, Zucchi E, Mazzini L, Pisano F, Gagliardi I, Patti F, Mandrioli J, Ferrante M, Vinceti M. Environmental and Occupational Risk Factors of Amyotrophic Lateral Sclerosis: A Population-Based Case-Control Study. Int J Environ Res Public Health. 2020 Apr 22;17(8):2882. doi: 10.3390/ijerph17082882.

  PMID: 32331298 BACKGROUND

• Alonso R, Pisa D, Marina AI, Morato E, Rabano A, Rodal I, Carrasco L. Evidence for fungal infection in cerebrospinal fluid and brain tissue from patients with amyotrophic lateral sclerosis. Int J Biol Sci. 2015 Apr 2;11(5):546-58. doi: 10.7150/ijbs.11084. eCollection 2015.

  PMID: 25892962 BACKGROUND

• Fiore M, Parisio R, Filippini T, Mantione V, Platania A, Odone A, Signorelli C, Pietrini V, Mandrioli J, Teggi S, Costanzini S, Antonio C, Zuccarello P, Oliveri Conti G, Nicoletti A, Zappia M, Vinceti M, Ferrante M. Living near waterbodies as a proxy of cyanobacteria exposure and risk of amyotrophic lateral sclerosis: a population based case-control study. Environ Res. 2020 Jul;186:109530. doi: 10.1016/j.envres.2020.109530. Epub 2020 Apr 15.

  PMID: 32335431 BACKGROUND

• Sales de Campos P, Olsen WL, Wymer JP, Smith BK. Respiratory therapies for Amyotrophic Lateral Sclerosis: A state of the art review. Chron Respir Dis. 2023 Jan-Dec;20:14799731231175915. doi: 10.1177/14799731231175915.

  PMID: 37219417 BACKGROUND

• Li JY, Sun XH, Cai ZY, Shen DC, Yang XZ, Liu MS, Cui LY. Correlation of weight and body composition with disease progression rate in patients with amyotrophic lateral sclerosis. Sci Rep. 2022 Aug 2;12(1):13292. doi: 10.1038/s41598-022-16229-9.

  PMID: 35918363 BACKGROUND

• Bond L, Ganguly P, Khamankar N, Mallet N, Bowen G, Green B, Mitchell CS. A Comprehensive Examination of Percutaneous Endoscopic Gastrostomy and Its Association with Amyotrophic Lateral Sclerosis Patient Outcomes. Brain Sci. 2019 Sep 4;9(9):223. doi: 10.3390/brainsci9090223.

  PMID: 31487846 BACKGROUND

• Floeter MK, Mills R. Progression in primary lateral sclerosis: a prospective analysis. Amyotroph Lateral Scler. 2009 Oct-Dec;10(5-6):339-46. doi: 10.3109/17482960903171136.

  PMID: 19922121 BACKGROUND

• Syrow L, Calderwood D, Newton C; An Integrative Medicine approach may slow disease in ALS patients compared to standard of care: A pilot observational study. Annals of Neurology Volume 96, Number S32, 149th Annual Meeting American Neurological Association pp. S278-279 (September 2024) https://onlinelibrary.wiley.com/doi/10.1002/ana.27051

  BACKGROUND

• Harrison D, Mehta P, van Es MA, Stommel E, Drory VE, Nefussy B, van den Berg LH, Crayle J, Bedlack R; Pooled Resource Open-Access ALS Clinical Trials Consortium. "ALS reversals": demographics, disease characteristics, treatments, and co-morbidities. Amyotroph Lateral Scler Frontotemporal Degener. 2018 Nov;19(7-8):495-499. doi: 10.1080/21678421.2018.1457059. Epub 2018 Apr 2.

  PMID: 29607695 BACKGROUND

• Crayle J, Lutz M, Raymond J, Mehta P, Bedlack R. Study of "ALS reversals": LifeTime environmental exposures (StARLiTE). Amyotroph Lateral Scler Frontotemporal Degener. 2023 Feb;24(1-2):54-62. doi: 10.1080/21678421.2022.2090846. Epub 2022 Jul 1.

  PMID: 35775279 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Interventions

Minerals; Meditation; Psychotherapy; Diet; Exercise; Physical Therapy Modalities; Occupational Therapy; Speech Therapy; Steam Bath; Massage; Restraint, Physical

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Behavioral Disciplines and Activities; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Rehabilitation of Speech and Language Disorders; Balneology; Hyperthermia, Induced; Therapy, Soft Tissue; Musculoskeletal Manipulations; Behavior Control; Immobilization; Investigative Techniques

Study Officials

• William L Cowden, MD

  Chair of Scientific Board of Academy of Comprehensive Integrative Medicine, Co-chair of Medical Advisory Team of Healing ALS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Healing ALS Study Administrator

CONTACT

1-973-714-4621; Study@HealingALS.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: November 18, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): February 5, 2036
• Study Completion (Estimated): March 31, 2036
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The investigators will share IPD starting 1 year after publication and will make it available for 3 years from that date.
• Access Criteria: Researchers who provide a methodologically sound proposal as assessed by our Scientific Advisory Team.

Locations

US (1)